Job OverviewPerform, manage and co-ordinate activities for assigned opportunities/ projects. Perform data mining and analysis, formulate recommendations and present to internal and potentially external stakeholders. Train and support new team members / junior staff. Make recommendations for process improvements.Essential Functions• Accountable to ensure IQVIA planning services are providing a competitive edge in winning new business. Take independent responsiblity for IQVIA commitments of future studies by delivering accurate and robust country, site or enrollment strategies in support of opportunities including but not limited to requests for proposals, early engagements, re-bids and potentially awarded studies.• Support the development of materials related to feasibility or site lists or enrollment strategies for customer bid defense meetings or internal customers such as Therapeutic Strategy Leads, Medical Leads or business development• Collaborate with key stakeholders and IQVIA project teams to resolve issues• Prepare for planning meetings by conducting research into therapeutic areas using databases, scientific literature, the internet and expert medical knowledge• Lead planning meetings with internal stakeholders including Medical Directors, Therapeutic Strategy Leads, Business Developers, Sales Staff and Program Directors. Present results of data gathering and analysis activities.• Undertake therapeutic training, as necessary, and keep abreast of developments in clinical research• Train and support new team members.• Proficient with planning tools, demonstrate an in depth understanding of system features and functions to know what features are best used to accomplish an accurate country, site or enrollment strategy.Qualifications• Bachelor's Degree Healthcare or Biological Science Req• 3 years related experience in clinical research. Equivalent combination of education, training and experience.• Clinical/project management experience is preferred.• General knowledge and understanding of company clinical systems, procedures and corporate standards.• Good knowledge of medical terminology, GCP, FDA regulations, and Drug Development process.• In-depth understanding of clinical research.• Excellent communication, organizational and interpersonal skills.• Fluid report writing in English• Strong computer literacy, including well-developed computer skills in applicable software.• Ability to work independently and effectively prioritize tasks.At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
Job OverviewDirect and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.Essential Functions• Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines. Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required. Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan. Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required. Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements. Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team. Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations• identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan. Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required. Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents. Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable). Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information. May take a lead role in developing long standing relationships with preferred IQVIA customers. Deliver presentations/training to clients, colleagues and professional bodies, as required. May be involved in activities related to monthly study budget planning and reviews.Qualifications• Bachelor's Degree Life sciences or related field Req• 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education, training and experience.• Strong negotiation and communication skills with ability to challenge• Excellent interpersonal skills and strong team player• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects• Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process• Demonstrated proficiency in using systems and technology to achieve work objectives• Good regulatory and/or technical writing skills• Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines• Good leadership skills, with ability to motivate, coach and mentor• Good organizational and planning skills• Ability to exercise independent judgment taking calculated risks when making decisions• Good presentation skills• Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.• Excellent understanding of study financial management• Proven ability to work on multiple projects balancing competing prioritiesIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Analyst / Associate Consultant, Real World Solutions(Epidemiologist)The OpportunityIQVIA’s Real World Solutions is currently recruiting for an Analyst / Associate Consultant, Epidemiologist to focus on real world evidence generation across APAC region. The successful applicant will have the opportunity to work with experienced healthcare industry partners, academic researchers, consultants, and data scientists. He/she will support the design, development, and delivery of a wide range of projects to our clients including database analytics, HEOR and patient centered research (surveys, DCE, Delphi). Projects range in complexity from supporting study design, medical writing i.e., protocols, study reports, abstracts, manuscripts, research analysis and problem solving to assisting the development of recommendations for clients.Responsibilities:Support development of epidemiological study design, scientific and medical writingUndertake epidemiological analyses including descriptive outputs, synthesis and generation of evidence around key epidemiological features for real world studies Perform desk research, literature reviews and data analysisWork closely with various project team members including project managers, epidemiologists, data scientists, statisticians and consultants across APAC and other regions in multi-country studiesMaintain in-depth understanding of real-world study designs and analytical methods Support project delivery including presentations and other client deliverables, and participating in client meetings and workshopsDevelop and implement strategies to ensure accurate and timely delivery of analysis resultsExcellent communications skills to effectively communicate complex concepts to internal and external stakeholdersSkills & Experience Required:MPH, MSc or PhD (or an equivalent degree) in social science, epidemiology, public health, or a related disciplineSound epidemiological, analytical and writing skills Proactive, flexible, resourceful and able to work independentlyStrong analytical and problem-solving mindset along with excellent written and verbal communication skillsExperience in designing and executing epidemiological studiesExperience with mixed-methods epidemiological studies, with expertise in both qualitative and quantitative research methodologies will be preferredPrior healthcare-related and qualitative, quantitative and mixed-methods survey platforms experience will be an added advantageAble to work independently in a multidisciplinary and culturally diverse teamExcellent team player and self-motivatedFluency in English (spoken and written)IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Job OverviewProvides high quality, on-time input to client projects in the life sciences field. Assignments range in complexity from basic analysis and problem solving to assisting in the development of more complex solutions. May serve as project leader for small teams or work streams.Essential Functions• Assists with the review and analysis of client requirements or problems and assists in the development of proposals and client solutions.• Assists in the development of detailed documentation and specifications.• Performs quantitative or qualitative analyses to assist in the identification of client issues and the development of client specific solutions.• Assists in the design/structure and completion of presentations that are appropriate to the characteristics or needs of the audience.• Develops, and may present, complete client deliverables within known/identified frameworks and methodologies.• Proactively develops a basic knowledge of consulting methodologies and the life sciences market through the delivery of consulting engagements and participation in formal and informal learning opportunities.• Engagement based responsibilities are assigned and managed by Senior Consultants, Engagement Managers or Principals.Qualifications• Bachelor's Degree • 3-5 years of related experience in consulting• Works willingly and effectively with others in and across the organization to accomplish team goals.• Knowledge and understanding of the fundamental processes of business, their interaction, and the impact of external/internal influences on decision making, growth and decline.• Knowledge of consulting methods, tools and techniques, related to one’s functional area.• Knowledge of current events and developments within an industry and major competitors.• Knowledge and understanding of the marketplace.• Knowledge of professional/trade associations, key people and companies.• Effective time management skills.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Job OverviewUnder guidance, provides support in applying statistical methodologies to assigned research projects.Essential Functions• Provides statistical methodology support in the delivery of standard and custom studies.• Applies statistical design and methodology to meet client information needs, conducts statistical analyses to derive conclusions from the study and assists in preparing written summaries of study results.• Works as part of a team in preparing analysis plans and statistical reports and performs validation of statistical analysis. Works on projects of limited scope within defined procedures and practices.• Ability to carry out moderate analysis and information gathering to resolve problems on non-routine matters.Qualifications• Bachelor's or Master's degree, pharmaceutical related preferred；• At least 3-5 years in consulting or market research with pharmaceutical and related industry experience;• Strong consulting/market research skills and project experience, as well as project management and client communication skills;• Strong stress tolerance and problem solving skills.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Job OverviewUnder guidance, provides support in applying statistical methodologies to assigned research projects.Essential Functions• Provides statistical methodology support in the delivery of standard and custom studies.• Applies statistical design and methodology to meet client information needs, conducts statistical analyses to derive conclusions from the study and assists in preparing written summaries of study results.• Works as part of a team in preparing analysis plans and statistical reports and performs validation of statistical analysis. Works on projects of limited scope within defined procedures and practices.• Ability to carry out moderate analysis and information gathering to resolve problems on non-routine matters.Qualifications• Bachelor's Degree Statistics, Mathematics or related field Req Or• Master's Degree Statistics, Mathematics or related field Pref• Multivariate analysis, regression analysis and forecasting, sampling, and basic knowledge of SAS programming languages in both OC and mainframe environments; Advanced And• Ability to proactively identify complex problems and needs ad develop solutions/recommendations to solve problems. IntermediateIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Job OverviewPerform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.Essential Functions• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.• Assist with periodic review of study files for completeness.• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.Qualifications• High School Diploma or equivalent Req.• 3 years administrative support experience.• Equivalent combination of education, training and experience.• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.• Written and verbal communication skills including good command of English language.• Effective time management and organizational skills.• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.• Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.• Knowledge of applicable protocol requirements as provided in company training.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Job OverviewSecure and retain business through professional, consultative, proactive sales activities directed at decision-makers and decision influencers at existing and new clinical sponsors.Essential Functions• Actively prospect and leverage potential new business opportunities within specified customer account(s).• Cultivate strong, long-term relationships with key decision-makers within Account and develop in-depth knowledge of the customer organization.• Maintain general knowledge of all IQVIA services for appropriate cross-sell opportunities.• Aggressively pursue awareness of competitive activities, positioning and pricing, which includes specific reasons for awards and non-awards.• Identify and respond to customer needs in order to define potential opportunities. Propose appropriate strategy/solution to customer.• Coordinate with contracts/proposals to develop proposal.• Work with operations and functional managers to identify sales team and prepares and leads the sales presentation. Educate team participants in customer culture, operational needs/methods and sales techniques needed to close the sale.• Handle follow-up related to the sale and drive completion of contractual documents.• Adapt successful strategies and tactics to meet market demands and financial targets.• Maintain high visibility within customer organization. Monitor customer satisfaction by communicating regularly with customer.• Establish and execute a comprehensive sales plan for each target account. Ensure appropriate strategy/solution is proposed to customer. Monitor actions and results against plans.• Analyze potential opportunities and develop sales plans for each target account. Ensure appropriate strategy/solution is proposed to customer.• Monitor actions and results against plans.• Record all customer sales related activities in CRM system.• Prepare sales activity report for Sales Management as required.• Serve as a liaison between the customer and technical and operational groups at IQVIA, Inc.Qualifications• Bachelor's Degree in Business Management• 10 years related experience, including 3 years of relevant industry (CRO/Pharmaceutical) and/or sales experience• Equivalent combination of education, training and experience• Proven track record at mid-level and high-level contacts• Strong organizational, planning, project management skills• A developing record of customer contacts at the outsourcing, procurement and mid - management level• Excellent Business/Industry awareness and a thorough understanding of industry trends and impact on the business• Excellent analytical skills in assessing and interpreting customer business data• Ability to maintain demanding timelines• Ability to influence others internally and externally• Adaptability and flexibility to changing priorities• Demonstrated ability to work creatively in a fast-paced environment• Exceptional attention to detail and ability to work simultaneously on multiple priorities• Ability to work independently and as a team player• Excellent skills using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel• Excellent oral and written communication skills• Ability to establish and maintain effective working relationships with coworkers, managers and clientsIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Position SummaryThe SEAT (Southeast Asia and Taiwan) Rare Diseases Lead directly reports to Senior Director, Rare Diseases EU & Int'l, Global Rare Diseases Business Unit.The function leads the full spectrum of activities dedicated to the Rare Diseases product portfolio and coordinates the implementation and execution of strategies and projects derived from the company international brand plans to achieve the Country full potential.In addition, the SEA Rare Diseases Lead holds responsibility for local sales performance and ensuring that partners implement the appropriate strategies and actions necessary to achieve commercial objectives. This role is pivotal in driving alignment and execution across all stakeholders to meet business goals effectively.The role also requires the individual to spend a significant portion of their time working alongside partners in the field, ensuring close collaboration and effective support across the territory.Key Tasks and Responsibilities Develop and execute Customer brand plans. Liaise with Portfolio Brand and Medical Manager and other functionsIdentify, prioritize and execute critical commercialization activities for product portfolioDirect sales responsibility & country BU managementIncrease and optimize strategic level of the RD unitAlign brand strategies and convert them into local market and reimbursement settingsOrganize and run added value programs to guide the company through challenging RD market environmentGather and assess data on disease areas, indications, key customers and business environment (i.e. search and critically evaluate clinical literature, business sources and market research on incidence/prevalence, product profile, competitive therapies/ companies, key customers and related business issues)Help develop and support critical assumptions used to quantify the market and potential value of present and (potential) new products under multiple scenarios, including all country BU operating expense budgetsCoordinate efforts in team environment and with other departments (Mkt Access, PV&QA, BK, local CS, supply, finance, HR, legal, regulatory, advocacy, etc.)Develop in-depth understanding of the RD products related markets, therapeutic areas and dynamics as well as critical success factorsEnsure, through direct involvement, the development and implementation of the sales plans to achieve sales targets Effectively lead the planning, organization, leadership and control of the business unit through the appropriate processes and in accordance with the client philosophy, values and ethical codeRequirements and Qualifications Qualifications will include a minimum of University level educationLife science, medical background a plusMinimum 5+ years commercial experience/Market Access in rare diseases is requiredStrong marketing and sales experience in RD field. In alternative a previous marketing role with extensive external activities and KOL contacts Holistic understanding of the APAC pharmaceutical ecosystems. Knowledge of local pricing and reimbursementExperience in RD product launch Strong market knowledgeSolid financial acumenProven People Management ExperiencePersonality criteriaThe successful candidate will be a self-reliant, self-motivated entrepreneur with a demonstrated ability to build businesses as well as enduring, authentic and productive internal collaborations.Team player and able to work with several disciplines in a multicultural environmentStress resilientProblem solving: leads others to solve complex problems and takes a broad perspective to identify innovative solutions.High flexibility and ability to work in a matrix organizationAbility to manage complexity and build trustGood analytical and tactical skillsFluent in English and MandarinIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Job OverviewProvides high quality, on-time input to client projects in the life sciences field. Assignments typically require analysis and problem solving within an established framework.Essential Functions• Under direct supervision, assists with the review and analysis of client requirements or problems and assists in the development of client solutions.• Assists in the development of detailed documentation and specifications.• Under close supervision, performs quantitative or qualitative analyzes to assist in the identification of client issues and the development of client specific solutions.• Assists in the design and structure of presentations that are appropriate to the characteristics or needs of the audience.• Proactively develops a basic knowledge of consulting methodologies and the life sciences market through the delivery of consulting engagements and participation in formal and informal learning opportunities.• Engagement based responsibilities are assigned and closely managed by Consultants, Senior Consultants, Engagement Managers or Principals.Qualifications• Bachelor's Degree• 0-3 years of related experience• Works willingly and effectively with others in and across the organization to accomplish team goals.• Knowledge and understanding of the fundamental processes of business, their interaction, and the impact of external/internal influences on decision making, growth and decline.• Knowledge of consulting methods, tools and techniques, related to one’s functional area.• Knowledge of current events and developments within an industry and major competitors.• Knowledge and understanding of the marketplace. Knowledge of professional/trade associations, key people and companies.• Effective time management skills.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Job OverviewProvides high quality, on-time input to client projects in the life sciences field. Assignments range in complexity from basic analysis and problem solving to assisting in the development of more complex solutions. May serve as project leader for small teams or work streams.Essential Functions• Assists with the review and analysis of client requirements or problems and assists in the development of proposals and client solutions.• Assists in the development of detailed documentation and specifications.• Performs quantitative or qualitative analyses to assist in the identification of client issues and the development of client specific solutions.• Assists in the design/structure and completion of presentations that are appropriate to the characteristics or needs of the audience.• Develops, and may present, complete client deliverables within known/identified frameworks and methodologies.• Proactively develops a basic knowledge of consulting methodologies and the life sciences market through the delivery of consulting engagements and participation in formal and informal learning opportunities.• Engagement based responsibilities are assigned and managed by Senior Consultants, Engagement Managers or Principals.Qualifications• Bachelor's Degree • 3-5 years of related experience• Works willingly and effectively with others in and across the organization to accomplish team goals.• Knowledge and understanding of the fundamental processes of business, their interaction, and the impact of external/internal influences on decision making, growth and decline.• Knowledge of consulting methods, tools and techniques, related to one’s functional area.• Knowledge of current events and developments within an industry and major competitors.• Knowledge and understanding of the marketplace.• Knowledge of professional/trade associations, key people and companies.• Effective time management skills.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Services Overview: The services requested are for Statistical Programming for clinical trials Phase I – IV utilizing SAS (Base and Macros) and R.Deliverables: Services rendered will adhere to applicable client SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc. Creation of ADaM datasets based on current ADaM standards.Creation of Tables, Listings and Figures following client specificationsCreation of Subject Narratives following client templates to support Narrative development.Creation of other ancillary data streams including (but not limited to) clinical registry reporting files (e.g. Clintrials.gov, EudraCT), Bioresearch monitoring reports (BIMO).QC of all programmed outputCreation and/or maintenance of detailed specification documentationDevelopment and validation of electronic submission packages that comply with submission requirements from FDA, EMEA and other regulatory agencies as needed.Includes support for standalone studies as well as integration of data across studies.Specific for CDSA – Analysis Standards focus area:The service holder is responsible to design, develop and maintain SAS code that is generic and that covers many trial types, can run on many study designs and meet study specific situations based on high reliable study metadata specifying the design and study specific situations.The service holder defines and maintains standard clinical data analysis metadata for use in clinical trials, including the traceability from Analysis Datasets and Analysis Results (ADaM) to Study Data Tabulation Datasets (SDTM).The service holder pre-configures the standards in line with the data lifecycle plan while maintaining the traceability and lineage of the data. The service holder documents and correctly manages the lineage between master standards and the many pre-configured standards.Education and Experience Requirements/Qualifications: Bachelor’s degree or higher and / or equivalent in computer science, mathematics, or other scientific field (or equivalent theoretical/technical depth). Advanced degree (Master's, PhD or equivalent) preferred for Level 4.Demonstrated written and verbal communication.Ability to work remotely.Knowledge of SAS is must and R, Python is a plus.Minimum 4+ years of experienceHigh level experience in the implementation of SAS (Base and Macro) in the analysis of clinical trial dataWorking knowledge of clinical trial data (Study population, safety, efficacy, PK/PD) in the therapeutic are being serviced.Demonstrated understanding of current industry standards for submission of clinical trial data.Specific for CDSA – Analysis Standards focus area:Basic knowledge in industry standards, specifically Study Data Tabulation Model (SDTM), Controlled Terminologies (CT) and related Analysis Data Models (ADaM)Relevant operational experience in analysis standards (ADaM metadata and SAS Code) is preferred.Experience with Therapeutic Area User Guides (TAUG) is a plus.R Skills:Possesses foundational R programming capabilities that enable working with data and performing simple analyses.Demonstrates understanding of R syntax and basic data structures, can import and export datasets, and create basic data visualizations.These skills support straightforward data manipulation and exploratory analysis tasks.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Job Overview【此職缺為派遣性質，派遣公司為法定雇主。官網投遞作業僅為艾昆緯內部系統建檔流程 】Provides administrative and/or technical support.Essential Functions• Responsible to reconcile SAP Grant Payment Report to Excel Grant Payment Report for assigned Sponsors’ studies, as well as reconcile the total GPS Sponsor balance to the Corporate Sponsor Balance on a monthly basis per SSAE16 Controls• Responsible to accurately complete all necessary journal entries as assign• Responsible to quality review CTA and Payment Intake form setups to determine appropriate SAP vendor and payment method for Payments staff for assigned Sponsor’s studies, inclusive of bank entry validation for the Accounting dept.• Responsible for SharePoint tracker completion for assigned sponsors.• On an annual basis, assist with 1099 and other country tax reporting as assigned• Special projects involving maintenance of the vendor database in SAP, and SOP Maintenance, as required• Other duties as assignedQualifications• Bachelor's Degree Pursuing degree Req•• Appropriate verbal and written communication skills to function within a professional work environment.• Evidence of effective problem – solving, analytical, and critical thinking skills.• Proficiency in alignment with the desired role placement• Evidence of strong team work and communication skills.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Job OverviewManage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Data Management (DM) team to provide high quality data management products that meet customer needs. Provide leadership to the team in the areas of project planning, execution, and close-out; Overview of financial management for data management activities; communications; and milestone deliverables. Perform role of Data Team Lead (DTL). Essential Functions• Gather Study Set up requirements through discussion and communication with relevant stakeholders.• With Minimal guidance - support, overview of validation of new Device integrations.• Oversight & Perform regular Data cleaning activities to ensure clean data with quality and timely deliverables to sponsor.• Ensure that all the deliverables are of expected quality standards and meet customer expectations.• With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW).• Support Training of New joiners.• Lead internal study meetings and internal/ sponsor audits and participate in Study Kick off meetings and other sponsor meetings.• Tracks and manages the projects, oversee project progress, identify risks and take corrective action to rectify any errors as recommended as required.• With Guidance manage & oversight the implementation of new technology / database revisions.• Work closely with the programming team for process innovation and automation.• Be compliant to trainings and eSOP reading.• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions.• Communication with Line Manager, and other team members across functions should be collaborative.• Perform other duties as directed by Line Manager.Qualifications• Bachelor's Degree In health, clinical, biological or mathematical sciences, or related field with proven experience in Data Management Req• 3 -4 years direct Data Management experience, including a minimum of 1 year as a CDM project lead. Pref• English Fluency Spoken and English Advanced• Advanced computer applications like Microsoft excel, word, Inbox etc Advanced• Should have Advanced understanding of Drug development lifecycle and Overall Clinical research process AdvancedIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Job OverviewManage a team of clinical staff working in support of clinical studies to ensure projects are appropriately resourced and employees are trained and meeting project objectives.Essential Functions• Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, assessing performance and guiding professional development, rewarding and disciplining employees, and addressing employee relations issues and resolving problems.• Participate in the selection for hiring new employees by conducting candidate review and participating in the interviewing process. Ensure that new employees are properly onboarded and trained.• Ensure that staff has the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and training experiences, as applicable.• Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies based on their experience and training.• Manage the quality of assigned staff's clinical work through regular review and evaluation of work product.• Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.• Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.• May collaborate with other clinical teams and other functional leadership to manage project related challenges and to achieve exemplary customer service.• Participates in corporate or organizational departmental quality or process improvement initiatives.Qualifications• Bachelor's Degree Degree in scientific discipline or health care preferred. Pref• Prior clinical trial experience including experience in a management/leadership capacity or equivalent combination of education, training and experience.• In-depth knowledge of applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).• Good leadership skills.• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.• Written and verbal communication skills including good command of English.• Excellent organizational and problem solving skills.• Effective time management skills and ability to manage competing priorities.• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Job OverviewPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.Essential Functions• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.• Prepare site regulatory documents, reviewing for completeness and accuracy.• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.• Review and provide feedback to management on site performance metrics.• Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.• Inform team members of completion of regulatory and contractual documents for individual sites.• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.• Perform quality control of documents provided by sites.• May have direct contact with sponsors on specific initiatives.Qualifications• Bachelor's Degree Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.• 3 years clinical research experience, including 1 year experience in a leadership capacity. Equivalent combination of education, training and experience.• In-depth knowledge of clinical systems, procedures, and corporate standards.• Good negotiating and communication skills with ability to challenge, if applicable.• Effective communication, organizational, and interpersonal skills.• Ability to work independently and to effectively prioritize tasks.• Ability to manage multiple projects.• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.• Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company’s Corporate Standards.• Understanding of regulated clinical trial environment and knowledge of drug development process.• Ability to establish and maintain effective working relationships with coworkers, managers and clients.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Job OverviewReview, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.Essential Functions• To Prioritize and complete the assigned trainings on time.• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.• To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information• determining initial/update status of incoming events• database entry• coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines.• Ensure to meet quality standards per project requirements.• Ensure to meet productivity and delivery standards per project requirements.• To ensure compliance to all project related processes and activities.• Creating, maintaining and tracking cases as applicable to the project plan.• Identify quality problems, if any, and bring them to the attention of a senior team member.• To demonstrate problem solving capabilities.• To mentor new teams members, if assigned by the Manager.• Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.• 100% compliance towards all people practices and processes• Perform other duties as assigned.Qualifications• High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences Req• An Individual with a minimum of a Bachelor’s Degree in scientific or healthcare discipline or allied life sciences graduation with 1-1.5 years of relevant experience. Req• Good knowledge of medical terminology. Intermediate• Working knowledge of applicable Safety Database. Beginner• Knowledge of applicable global, regional, local clinical research regulatory requirements. Beginner• Excellent attention to detail and accuracy. Beginner• Good working knowledge of Microsoft Office and web-based applications. Beginner• Strong organizational skills and time management skills. Beginner• Strong verbal/written communication skills. Intermediate• Self-motivated and flexible. Intermediate• Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate• Ability to multi-task, manage competing priorities and deadlines. Beginner• Ability to delegate to less experienced team members. Beginner• Willingness and aptitude to learn new skills across Safety service lines. Beginner• Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Beginner• Ability to work as a Team Player, contribute and work towards achieving Team goals. Beginner• Ensure quality of deliverables according to the agreed terms. Beginner• Demonstration of IQVIA core values while doing daily tasks Beginner• Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Beginner• Regular sitting for extended periods of time. Beginner• May require occasional travel. Beginner• Flexibility to operate in shifts. BeginnerIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Job OverviewPerform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.Essential Functions• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.• Collaborate and liaise with study team members for project execution support as appropriate.• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.Qualifications• Bachelor's Degree Degree in scientific discipline or health care preferred. Req• Requires at least 1 year of on-site monitoring experience. Req• Equivalent combination of education, training and experience may be accepted in lieu of degree. Req• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).• Good therapeutic and protocol knowledge as provided in company training.• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).• Written and verbal communication skills including good command of English language.• Organizational and problem-solving skills.• Effective time and financial management skills.• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
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